A review of the internal documentation only showed a small anomaly on segmentation on the femur and planning on the tibia.The segmentation anomaly however, could have had only a minor effect on the overall fit and stability of the guide on the patient's femur.The anomaly in the planning step does not have an influence on the total resection level of the tibia and therefore does not have an impact on the overall outcome of the surgery on the tibia component.Therefore, it can be concluded that no root cause could be found to explain the alleged issue by the complainant.In addition, the zimmer implant that was used is subject to a class ii recall ((b)(4)) because of potential implant loosening.Therefore, it is more likely the complaint is caused by a problem in the implant than an issue with the materialise instruments.Should additional information become available, that changes this assessment, an amended medical device report will be filed.
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It was reported that the patient received an implant, utilizing zimmer patient specific instruments guides, in 2013.She is experiencing pain similar to the arthritis she experienced before the knee replacement as well as grinding and popping.Revision is scheduled.X-ray showed implant is loosening.
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